A Randomized, Double-blind, Placebo-controlled First-in-Human Study of Single and Multiple Doses of ALXN2080 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.
详细描述
Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
- •Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m
- •Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.
排除标准
- •Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- •History of hypersensitivity to any ingredient contained in the study intervention.
- •Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
- •Known or suspected history of drug or alcohol abuse or dependence.
- •Current tobacco users or smokers.
- •Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- •For females: pregnant, breastfeeding, or intending to conceive during the course of the study.
研究组 & 干预措施
SAD - Cohort 1
Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo.
干预措施: ALXN2080 (Drug)
SAD - Cohort 1
Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo.
干预措施: Placebo (Drug)
SAD - Cohort 2
Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo.
干预措施: ALXN2080 (Drug)
SAD - Cohort 2
Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo.
干预措施: Placebo (Drug)
SAD - Cohort 3
Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo.
干预措施: ALXN2080 (Drug)
SAD - Cohort 3
Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo.
干预措施: Placebo (Drug)
SAD - Cohort 4
Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo.
干预措施: ALXN2080 (Drug)
SAD - Cohort 4
Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo.
干预措施: Placebo (Drug)
SAD - Cohort 5
Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo.
干预措施: ALXN2080 (Drug)
SAD - Cohort 5
Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo.
干预措施: Placebo (Drug)
SAD - Cohort 6
Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo.
干预措施: ALXN2080 (Drug)
SAD - Cohort 6
Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo.
干预措施: Placebo (Drug)
MAD - Cohort 1
Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
干预措施: ALXN2080 (Drug)
MAD - Cohort 1
Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
干预措施: Placebo (Drug)
MAD - Cohort 2
Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
干预措施: ALXN2080 (Drug)
MAD - Cohort 2
Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
干预措施: Placebo (Drug)
MAD - Cohort 3
Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
干预措施: ALXN2080 (Drug)
MAD - Cohort 3
Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
干预措施: Placebo (Drug)
MAD - Cohort 4
Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
干预措施: ALXN2080 (Drug)
MAD - Cohort 4
Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 through up to Day 28
次要结局
- Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080(Up to 168 hours postdose)
- Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080(Up to 168 hours postdose)